Clinical Trial: Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy

Brief Summary: The purpose of this study is to determine whether Valacyclovir treatment, administered during pregnancy after proven primary maternal Cytomegalovirus (CMV) infection, reduces fetal transmission rates and prevents fetal injury in cases of fetal infection.

Detailed Summary:

A randomized, double-blind, placebo-controlled study.

Participants: Pregnant women over 18 years of age with serologically proven, primary CMV infection during the first trimester

Intervention: After informed consent and randomization, participants in the treatment group will receive Valacyclovir at a dose of 8 g/d. Participants in the control group will receive the same amount of daily pills containing placebo. Treatment will continue until amniocentesis, which will determine if the fetus was infected.


Sponsor: Rabin Medical Center

Current Primary Outcome: CMV Polymerase Chain Reaction (PCR) in amniotic fluid [ Time Frame: minimum 21 weeks gestation ]

amniocentesis will be performed no earlier than 21 weeks gestation, and at least 7 weeks after estimated seroconversion occured. Therefore, the time frame for amniocentesis is estimated between 21 weeks gestation to 28 weeks gestation


Original Primary Outcome: Same as current

Current Secondary Outcome: Clinical evidence of symptomatic congenital CMV infection [ Time Frame: within 1 week after delivery ]

laboratory, sonographic or clinical evidence of symptomatic CMV infection present after birth


Original Secondary Outcome: Same as current

Information By: Rabin Medical Center

Dates:
Date Received: January 18, 2015
Date Started: November 2015
Date Completion: March 2021
Last Updated: April 12, 2017
Last Verified: April 2017